Tag: Dr. Richard Maundrell

Posted By Richard Maundrell, Associate Professor, Lakehead University

In 1994 changes to the Food and Drugs Act made Health Canada responsible for the regulation of natural health products and homeopathic medicines (NHP’s). Since then, thousands of NHP’s have been approved by Health Canada as safe and effective. I argue that Health Canada’s criteria for efficacy in relation to NHP’s in particular are inadequate and that its certification of NHP’s is a betrayal of the trust that health care consumers have placed in a bureaucracy that is responsible for the regulation of prescription medicines. In Part One of this two-part blog series, I explained what homeopathic medicine is and why it is pharmacologically implausible. In Part Two, I look at Health Canada’s certification process and the problems with its criteria for efficacy in application to NHP’s.

Part II

As I explained in Part I, there is no scientific reason for believing that preparations at homeopathic levels of dilution can be chemically or biologically active, and the best clinical evidence to date supports the conclusion that homeopathic medicines are nothing more than placebo treatments. Nevertheless, Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) has approved thousands of homeopathic products as safe and “effective” since it assumed responsibility for the regulation of natural health products, including homeopathic medications, in 2004. .

Many of these medicines are manufactured by major corporate entities such as Boiron that specialize in homeopathic medicines. Boiron, which reported worldwide sales of CAD $831 million dollars in 2014, produces the flu medication Oscillococcinum. It is listed in Health Canada’s Licensed Natural Health Products Database as a 200C medication consisting of hyper-diluted liver and heart tissue from the Muscovy duck (i.e. 200C=1 part active ingredient to 10400 parts diluent). Oscillococcinum is sold in Canadian pharmacies under Health Canada’s Homeopathic Medicine Number DIN-HM #80009268. The safety of such a product is beyond question because, pharmacologically speaking, there is nothing in it. But how can Health Canada certify it effective?

Through the Looking Glass…

The NNHPD requires those applying for approval of natural health products to submit evidence of efficacy. According to the application guidelines, five levels of evidence are accepted as proof of efficacy:

1. Well-designed systematic reviews and meta-analyses of randomized controlled trials or other clinical trials, OR At least one well-designed randomized controlled trial (preferably multi-centred)
   II. Well-designed clinical trials without randomization and/or control groups
   III. Well-designed descriptive and observational studies, such as correlational studies, cohort studies and case-control studies
   IV. Peer-reviewed published articles, conclusions of other reputable regulatory agencies, previous marketing experience, expert opinion reports, textbooks, homeopathic materia medica, homeopathic pharmacopoeias, homeopathic provings, homeopathic repertories
   V. References to a traditional use

This list reflects a descending order of methodological rigour, with the gold standard randomized clinical trial at the top and the appeal to traditional practice at the bottom. Applicants are advised that the use of Levels I-III type evidence is “encouraged,” although the guidelines recognise that “homeopathic materia medica and homeopathic provings are the most commonly available evidence”.

Homeopathic materia medica is the body of collective knowledge available on homeopathic medicine. It dates back to the 19th century and substantially relies on provings, a form of clinical experimentation unique to homeopathy, which involves testing medicinal substances on healthy subjects. As was discussed in Part I, homeopathy’s central tenet, the “law of similars,” holds that a substance which produces the symptoms of a disease in a healthy person will be effective in treating a disease which causes those same symptoms. Even proponents of homeopathy acknowledge that this proposition conflicts with the basic laws of physics, chemistry and pharmacology. Consequently the materia medica cannot contain any credible evidence of efficacy. Nevertheless, traditional use (Level V) is sufficient for NNHPD approval. This is a regulatory example of the logical fallacy known as the argumentum ad antiquitatem: the inference from the age of an idea or practice to the conclusion that it is good, reasonable or useful. If tradition were a reliable indicator of medicinal value, bleeding patients according to the four humours theory of disease would still be a viable treatment option.

To appreciate just how cosmetic Health Canada’s efforts at determining the efficacy of NHP’s are, consider a homeopathic medicine manufactured by Boiron with the brand name “Insulin” (DIN-HM #80016478). Certified safe and effective by Health Canada in 2010, homeopathic Insulin is a 12C medication, which means that it contains one part medicinal ingredient to 10-24 parts diluent – less than one molecule per litre. The non-medicinal ingredients in this product are listed as lactose and sucrose, making Boiron’s Insulin essentially a sugar pill. Health Canada’s approval of NHP’s is not contingent on the specification of intended use, and under “Recommended Use or Purpose,” the Health Canada NHP Database entry for Insulin simply states “homeopathic medicine.” However, one might reasonably anticipate confusion on the part of health care consumers confronted by a non-prescription medicine certified safe and effective by Health Canada, which goes by the same name as the hormone used in standard treatment for diabetes, a serious disease for which sugar pills are unlikely to offer an effective remedy. Boiron and other makers of homeopathic Insulin reinforce this confusion by promoting these products as effective treatment for diabetes.

What is Health Canada’s Mission?

Browsing Health Canada’s guidance documents and database of NHP’s is a “through the looking glass” experience. Just as Alice runs into the insurmountable absurdity of Humpty Dumpty’s declaration that words mean whatever he chooses them to mean,[1] one finds that Health Canada uses the word ‘efficacy’ in a way that bears no relation to its meaning in either conventional usage or medical science. Health Canada’s approval process for NHP’s preserves the appearance of evidence-based review, while indulging the magical thinking inherent in homeopathic doctrine. It is not a harmless indulgence, because it lends an aura of evidence-based due diligence to products that consumers may elect to use as alternatives to conventional treatments for serious treatable illnesses.

Even more worrisome is the recent trend toward using homeopathic medicines as alternatives to conventional vaccines for children.

Homeopathic vaccines or “nosodes” are ultra-diluted preparations derived from diseased tissues or excretions from a sick person or animal. Health Canada has approved over 150 nosodes, including Vagininum (DIN-HM #80012308), a product derived from the vaginal tissue of rabbits. Health Canada instituted changes to labelling requirements in September 2013 that required the addition of the following disclaimer to such products: “This product is not intended to be an alternative to vaccination.” This is a step forward, but, as I have demonstrated, the problems with Health Canada’s certification process for NHP’s go much further than labelling requirements.

The NNHPD describes its role as providing Canadians with ready access to natural health products that are “safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity.” The problem with that conception of its mission is that the scientific criteria necessary to assessing safety and efficacy of medicinal substances are not necessarily consistent with the values of philosophical and cultural diversity. Many natural health products and traditional medicines claim to have medicinal properties on grounds that are fundamentally incommensurable with modern medical science. As I demonstrated above, this is true of homeopathic medicine.

Canadians pride themselves on having built a multicultural society based on tolerance and respect for diversity, and Health Canada’s policy on NHP’s may in part be a consequence of privileging the social values of inclusion and tolerance over those of scientific merit. Notions of what constitute disease and health are indeed subject to cultural and historical variation in ways that exceed the philosophical and methodological boundaries of modern medical science. But products marketed as effective in the treatment of disease conditions defined by modern medical science should be expected to meet the same criteria for efficacy as those applied to prescription drugs. To do otherwise would be to betray the public trust.

Conclusion

Monitoring the safety and quality of consumer products is an appropriate function for a federal department that defines its role as a provider of “credible information, reliable advice and quality services” to the people of Canada. Consumers have a right to treatment choices just as they have the right to forego medical treatment altogether. What is crucial in regulating the alternative medical industry, however, is ensuring that consumers have the information necessary to make informed choices. Certifying homeopathic products as “effective” in the absence of compelling clinical evidence is misleading and could contribute to dangerous health care decisions. If there is a segment of the market in which the principle of truth in advertising should be assiduously upheld, it is in respect to medicines. A good place to start would be to stop certifying homeopathic medicines as effective and to start labelling them with the same disclaimer found on a website maintained by the British National Health Service: “There has been extensive investigation of the effectiveness of homeopathy. There is no good-quality evidence that homeopathy is effective as a treatment for any health condition.”

[1] Lewis Carroll, Through the Looking Glass (1871). Chapter 7.

Posted By Richard Maundrell, Associate Professor, Lakehead University

In 1994 changes to the Food and Drugs Act made Health Canada responsible for the regulation of natural health products and homeopathic medicines (NHP’s). Since then, thousands of NHP’s have been approved by Health Canada as safe and effective. I argue that Health Canada’s criteria for efficacy in relation to NHP’s in particular are inadequate and that its certification of NHP’s is a betrayal of the trust that health care consumers have placed in a bureaucracy that is responsible for the regulation of prescription medicines. In Part One of this two-part blog series, I explain what homeopathic medicine is and why it is pharmacologically implausible. In Part Two, I look at Health Canada’s certification process and the problems with its criteria for efficacy in application to NHP’s.

Part I

A decade has passed since Parliament revised the Food and Drugs Act to include natural health products (NHP’s) within the regulatory ambit of Health Canada. The legislation applies to products that had been available in the marketplace for years, but which had escaped regulation because they were neither foodstuffs nor prescription medicines. These products included vitamins, minerals and herbal remedies as well as homeopathic and traditional medicines. Initially, the changes seemed to be a promising development for consumer protection, because they required manufacturers of NHP’s to prove the medicinal claims they used to market their products. Properly executed, the regulation might have helped to rid the drug store shelves of products sold on the basis of misleading, exaggerated or outright fraudulent claims of medicinal properties. Unfortunately for Canadian healthcare consumers, that is not how things worked out. Just how misguided Health Canada’s policies have been in this area is evident in its regulatory policies concerning homeopathic medicines.

What is Homeopathy?

While homeopathy is often confused with herbal medicine, it is actually a distinct mode of alternative medical treatment conceived and developed in the late 18^th century by Samuel Hahnemann (1755-1843). Unlike modalities of alternative medicine that have emerged from traditional folk practice, homeopathy is based on theoretical principles. Its pharmacology is based on Hahnemann’s “Law of Similars”: the principle that a substance which produces the symptoms of a disease in a healthy person will be effective in treating a disease involving those same symptoms in someone who is ill. Thus a common homeopathic treatment for nausea is extracted from the root of the Carapichea ipecacuanha plant, which is known to cause nausea and vomiting in otherwise healthy subjects. Hahnemann developed this “fighting fire with fire” approach using “provings”: an experimental method that tests the effects of potential medications on healthy subjects rather than sick ones. Medicines developed in this way would invite obvious concerns about toxicity if not for the other founding principle of homeopathy, the “law of infinitesimals,” which asserts that the smaller a dose of medication the more powerful its effect.

Consistent with the law of infinitesimals, homeopathic medications are prepared through an elaborate process of dilution in which the “mother tincture” is mixed at a ratio of one part active ingredient to 100 parts solvent (usually water). From its initial dilution the preparation can be diluted again any number of times, each by a factor of 100. Thus a 1:100 or “1C” solution becomes a 2C solution by being diluted again by a factor of 100, yielding a ratio of medicinal ingredient to diluent of 1/100 x 1/100 or 1:10,000. Homeopathic medications are often 20C, which means that they are the product of a series of twenty dilutions, each by a factor of 100. Aside from dilution, the preparation of homeopathic medications involves “succussion” or rhythmic shaking so as to impart the “pharmacological message” of the original substance to the molecules of the diluent.[1]

Is Homeopathy Medicinally Effective?

According to conventional science, homeopathic preparations will quickly become biologically and medicinally ineffective as the dilution process proceeds. At 30C, for example, one part active ingredient will remain in 10⁶⁰ parts solvent. The chances that a single molecule of active ingredient will remain in a standard dose of 30C homeopathic medicine is one in a billion, billion, billion, billion.[2] In the face of the basic implausibility of Hahnemann’s principles, homeopaths have continued to search for a scientific grounding for their beliefs. In the 1980’s, biochemist Jacques Benveniste claimed that he had observed reactions in human basophil samples to homeopathic-scale dilutions of the anti-IgE antibody.[3] To explain his observation, he hypothesized the notion of “the memory of water”: the idea that water is somehow capable of retaining the chemical properties of substances that are immersed in it. However, Benveniste was unable to replicate these results when asked to do so under properly blinded conditions by an investigative team from the journal Nature.[4] This lack of replication has traditionally been the barrier preventing pre-clinical research in homeopathic ultra-dilution from acceptance as genuine science.[5] The homeopathic community has an onerous burden of proof to establish that homeopathic medicines should be considered anything but placebo treatments.

Hahnemann practised medicine in a time prior to the advent of scientific medicine and the germ theory of disease when blood-letting was still a common mode of treatment for many illnesses. If his treatments were ineffective, they were probably not noticeably less so than what his peers were offering.[6] However, in light of the progress medical science has made since Hahnemann’s time, as well as the scientific implausibility of homeopathy’s theoretical tenets, we might reasonably expect regulatory agencies like Health Canada to demand substantial evidence of efficacy in homeopathic medications. After all, extraordinary claims demand extraordinary evidence. Compelling evidence of efficacy in homeopathic medications, however, remains elusive.[7] In a report to the British House of Commons in 2010, an investigative committee examining published research on homeopathy stated that “systematic reviews and meta-analyses conclusively demonstrate that homeopathic products perform no better than placebos.” That finding was echoed by a similar study carried out for the Australian government in 2013. While noting the paucity of high-quality clinical studies on homeopathic treatments, its authors concluded: “the available evidence is not compelling and fails to demonstrate that homeopathy is an effective treatment for any of the reported clinical conditions in humans.”

Meta-analyses cited by the British and Australian studies filter out low quality studies and reserve the greatest significance for the results of randomized clinical trials (RCT’s). The effectiveness of a medication is most accurately measured across subject populations that, for comparison purposes, have been randomly assigned to treatment and control groups. Random distribution reduces the probability that extraneous differences between subjects might be mistaken for therapeutic effect. The use of controls enables the application of statistical methods to arrive at a picture of therapeutic effect that is as precise as possible in research on human subjects. RCT methodology has been refined continuously since its introduction, most importantly with the introduction of placebo controls and double-blinding that enables researchers to tune subject and researcher expectations out of their data.[8] The RCT became the most trusted method available to medical research because it provided the most effective means of eliminating confirmation bias from the interpretation of clinical outcomes: the very common and natural human tendency to assign undue significance to evidence that supports one’s beliefs and to discount evidence that counts against them. It is principally on the grounds of RCT data that regulatory agencies like Health Canada approve prescription drugs.

Health Canada holds NHP’s to a much lower set of standards than those which it applies to prescription drugs. Those who drafted Health Canada’s policies on the regulation of homeopathic medicines must know that they are too dilute to be pharmacologically effective, and yet Health Canada’s guidelines for the approval of homeopathic medicines stipulate 12C as the minimum allowable potency (in the homeopathic sense of the term ‘potency’). Given that homeopathic medicines commonly have a potency of 20C, the vast majority of homeopathic medicines meet this criterion.

There is no known causal mechanism by which a 12C solution, diluted as it is to one part in 10^-24, can have biological effects, medicinal or otherwise. At 12C dilution, it has become a significant possibility that not even a single molecule of the original substance remains. Unless we have reason to believe that water really does have a memory, a solution that contains no medicinal ingredient can have no medicinal effect. The same facts that make homeopathic products safe for non-prescription use explain why such products can have no medicinal benefits beyond placebo. This leads one to wonder what Health Canada’s certification of an NHP as “effective” actually means. This will be the subject of Part II.

[1] Simon Singh & Edzard Ernst, Trick or Treatment: The Undeniable Facts about Alternative Medicine, (New York: W W Norton,2008) at 98.

[2] Singh & Ernst, supra note 1 at 99.

[3] Elizabeth Davenas et al, “Human Basophil Degranulation Triggered by Very Dilute Antiserum Against IgE” (1988) 333 Nature 816.

[4] John Maddox, James Randi & Walter W Stewart, “High Dilution Experiments a Delusion” (1988) 334 Nature 287.

[5] AJ Vickers, “Independent Replication of Pre-clinical Research in Homoeopathy: A Systematic Review” (1999) 6:6 Research in Complementary Medicine 311.

[6] Steven Bratman, The Alternative Medicine Sourcebook: A Realistic Evaluation of Alternative Healing Methods, 2d ed (Los Angeles: Lowell House, 1999) at 104.

[7] Edzard Ernst, “Homeopathy: What Does the Best Evidence Tell Us?” (2010) 192:8 Medical Journal of Australia 458. (This article is a review of all systematic reviews conducted on homeopathy in the Cochrane Database of Systematic Reviews, which is generally considered the most reliable source of evidence.)

[8] Marcia L Meldrum, “A Brief History of the Randomized Controlled Trial: From Oranges and Lemons to the Gold Standard” (2000) 14:4 Hematology/Oncology Clinics of North America 745.